As far back as late 2005, C.R. Bard’s subsidiary Davol issued a number of recalls related to the Composix Kugel mesh patch product that it manufactured. It had been discovered that problems were occurring with the minimally invasive surgeries in which the Composix® Kugel Mesh Patches (“CK Patch”) was used. There were a number of reports of the plastic memory ring used in the device splintering into smaller pieces that would then migrate away from the original surgical site. This led Davol to recall the mesh. A second recall was issued in 2007 for similar problems related to these medical devices.
The FDA – the United States Food and Drug Administration – classified this recall as a Class I, which is the highest level that the FDA uses for its recalls. This designation provided evidence of just how seriously the agency took the potential danger these implanted devices represented to the American public.
This mesh product was created to serve as a patch and had a so-called “memory recoil ring” that was designed to permit the surgeon to insert the patch through a relatively small incision in the abdomen. However, it was later discovered that this ring could break or buckle after it was placed in the body, resulting in intense pain and complications that had the potential of being life-threatening.
Health Risks Caused by Bard Hernia Mesh Implants and patches
Based on a careful analysis carried out by the Food and Drug Administration that looked that the scientific literature and adverse event reports for such medical devices, the most frequently occurring adverse event for hernia repair operations are infection, pain, adhesion, hernia reoccurrence, abdominal obstruction, fistulas, bleeding, tissue perforation and seroma. Any of these could result in considerable discomfort and danger for the patients involved.
History of the Bard/Davol Recall
In January 2007, the total number of Composix Kugel Mesh devices the company had recalled had soared above 100,000. By this time, the FDA had gathered reports that indicated that some 34 memory rings on these devices had broken, with 21 of these incidents causing serious injury. One incident actually resulted in death.
Once it had been discovered that this flaw existed in the memory recoil ring, which allowed it to break or buckle during placement, the company’s recall notices were expanded upon and issued multiple times. In all cases, the FDA classified these recalls as Class I. Again, this recall level for medical devices indicates that they are potentially defective and dangerous and could possibly lead to extremely serious health issues or even the death of the patient involved.
Hernia mesh lawsuit against Bard/ Davol- allegations of defect
In the ck patch lawsuit filed by CHARLES A. EATON and WANDA EATON against DAVOL INC. and C. R. BARD INC., the Plaintiff’s alleged the following:
“The CK Patches, like the one implanted in Plaintiff Charles Eaton, at the time they
left the possession of Defendants were inherently dangerous for their intended use and were
unreasonably dangerous products which presented and constituted an unreasonable risk of danger and injury to Plaintiff as follows:
i. The CK Patch was sold in a defective condition by design and manufacture;
ii. The CK Patch as designed and manufactured was unsafe to Plaintiff;
iii. The CK Patch as designed and manufactured was unreasonably dangerous
iv. The CK Patch did not perform safely as an ordinary consumer/patient, like
Plaintiff, would expect;
v. The CK Patch as designed and manufactured was unsafe for its intended
vi. DAVOL and BARD failed to warn the end user about the dangers and risks
of the product;
vii. DAVOL and BARD knew the component parts of the CK Patch as
implemented through design and/or manufacture could cause injury to the
viii. Failing to implement an adequate, safe and effective “memory recoil ring”
and/or its interaction with the mesh of the CK Patch to withstand the
foreseeable stresses they would be subject to within the intra-abdominal
ix. Failing to avoid shrinkage, contraction and degradation of the CK Patch
and/or its components;
x. Failing to avoid migration of the CK Patch and/or its components from the
initial site of the hernia repair surgery;
xi. Any other acts or failures to act by DAVOL or BARD regarding the studying, testing, designing, developing, manufacturing, inspecting, producing, advertising, marketing, promoting, distributing, and/or sale of CK Patches for hernia repair surgery as will be learned during discovery.” Eaton v. Davol Inc. Case Number: PC-2017-0735, complaint. Providence Superior Court
Bard Defective Device Lawsuits
This is not the first time that Bard has encountered legal troubles and liability regarding its medical devices. It has a very poor safety record when it comes to such products. For instance, a state court in California awarded a woman $3.6 million after she demonstrated to the court’s satisfaction that Bard’s Avaulta Plus implant had caused her serious injury. These implants were later removed from the market, but the damage had already been done.
Many devices of questionable safety manufactured by this company are still available on the market, regardless of the fact that they may be dangerous. A number of lawyers have pointed out in court that Davol Bard has sold a large number of plastic mesh devices over the years in which they used a type of plastic that the plastic manufacturer indicated was not safe for implantation in humans. In documents presented in court, emails from within the company itself revealed discussions in which executives warned their coworkers not to tell plastic manufacturers they were using this particular plastic material in the medical devices they were manufacturing for placement in human beings.
In fact, in spite of the warnings it had received from these plastic manufacturers, Davol / Bard continued using the material in its vaginal mess devices and hernia repair meshes. They were technically able to do this because the mesh itself had been cleared for use through the FDA’s 510(K) system, which frequently permits medical manufacturers to place medical devices on the market without actually conducting human tests regarding their safety or efficacy. There are quite a few products manufactured by Davol /Bard that can result in problems, including:
• 3D Max
• Composix EX
• Perfix Plug